BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 27X1/2 RB

    MDR report key: 19527130 · Received June 13, 2024

    Report

    Report Number
    1911916-2024-00423
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    June 5, 2024
    Report Date
    June 19, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051091
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305109 AND LOT NUMBER 3179204. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL# 305109 BATCH# 3179204 IT WAS REPORTED BY CUSTOMER THAT THEY SELF-ADMINISTERING MEDICATION IV, CLIENT REPORTED MEDICATION LEAKED AT CONNECTION POINT BETWEEN NEEDLE TIP AND SYRINGE DESPITE BEING SECURELY ATTACHED. NOTED TO HAVE APPROXIMATELY 0.8 ML OF MEDICATION LEFT IN SYRINGE. DOSE SHOULD BE 1.4 ML. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. AHS MDIP REFERENCE NUMBER (ID): (B)(4) DATE OF INCIDENT (YYYY-MM-DD): ON (B)(6) 2024 SITE NAME/LOCATION: XXX LEVEL OF HARM: MINIMAL HARM AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: WHILE SELF-ADMINISTERING MEDICATION IV, CLIENT REPORTED MEDICATION LEAKED AT CONNECTION POINT BETWEEN NEEDLE TIP AND SYRINGE DESPITE BEING SECURELY ATTACHED. NOTED TO HAVE APPROXIMATELY 0.8 ML OF MEDICATION LEFT IN SYRINGE. DOSE SHOULD BE 1.4 ML. IMPACT OF INCIDENT: CLIENT RECEIVED LOWER DOSE THAN ORDERED. WHO WAS AFFECTED? PATIENT DEVICE INFORMATION DEVICE NAME/DESCRIPTION: NEEDLE HYPODERMIC PRECISION GLIDE REGULAR BEVEL 27 GAUGE X 0.5 INCH MANUFACTURER: BECTON DICKINSON CANADA INC MANUFACTURER CODE/MODEL: 305109 SERIAL OR LOT NUMBER: 3179204 DEVICE EXPIRY DATE (YYYY-MM-DD UNKNOWN SUPPLIER: (B)(4) SUPPLIER CATALOGUE NUMBER: 308-305109 WAS THE DEVICE RETAINED? NO

    Description of Event or Problem · 0

    MATERIAL# 305109. BATCH# 3179204. IT WAS REPORTED BY CUSTOMER THAT THEY SELF-ADMINISTERING MEDICATION IV, CLIENT REPORTED MEDICATION LEAKED AT CONNECTION POINT BETWEEN NEEDLE TIP AND SYRINGE DESPITE BEING SECURELY ATTACHED. NOTED TO HAVE APPROXIMATELY 0.8 ML OF MEDICATION LEFT IN SYRINGE. DOSE SHOULD BE 1.4 ML. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. AHS MDIP REFERENCE NUMBER (ID):(B)(4). DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2024. SITE NAME/LOCATION: XXX. LEVEL OF HARM: MINIMAL HARM. AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: WHILE SELF-ADMINISTERING MEDICATION IV, CLIENT REPORTED MEDICATION LEAKED AT CONNECTION POINT BETWEEN NEEDLE TIP AND SYRINGE DESPITE BEING SECURELY ATTACHED. NOTED TO HAVE APPROXIMATELY 0.8 ML OF MEDICATION LEFT IN SYRINGE. DOSE SHOULD BE 1.4 ML. IMPACT OF INCIDENT: CLIENT RECEIVED LOWER DOSE THAN ORDERED. WHO WAS AFFECTED? PATIENT. DEVICE INFORMATION. DEVICE NAME/DESCRIPTION: NEEDLE HYPODERMIC PRECISION GLIDE REGULAR BEVEL 27 GAUGE X 0.5 INCH. MANUFACTURER: BECTON DICKINSON CANADA INC. MANUFACTURER CODE/MODEL: 305109. SERIAL OR LOT NUMBER: (B)(6). DEVICE EXPIRY DATE (YYYY-MM-DD UNKNOWN. SUPPLIER: MEDLINE CANADA CORPORATION. SUPPLIER CATALOGUE NUMBER: 308-305109. WAS THE DEVICE RETAINED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794324 NEEDLE 27X1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3179204 30382903051091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown